BioReliance launches new genotoxicity testing service
firm's novel DNA damage testing tool as a service for biopharma
companies for the first time.
The Maryland-based contract research organisation (CRO) will offer Gentronix's GreenScreen HC in vitro assay as part of its portfolio of genotoxicity screening services. Before a drug can enter clinical trials in humans, the US Food and Drug Administration (FDA) requires that developers check it is not genotoxic and does not cause DNA in the nucleus of a cell to mutate. Typically, genotoxicty levels are tested by injecting the potential drug into live mice and then, after 24 to 48 hours, looking for damaged red blood cells formed in the bone marrow of the mice. But detecting compounds with genotoxic liabilities earlier in the drug development means that fewer enter preclinical development, minimising delays to clinical trials, costly mechanistic studies and the unnecessary use of animal testing. As a result, a growing number of companies have launched in vitro genotoxicity tests that can be used earlier in the drug discovery process "There are several standard in vitro mammalian cell genotoxicity assay tests on the market but they generate a high number of false positive results for compounds that turn out to be negative in animal studies, which causes disruption in the decision making," Peter McCulloch, director of business development at Gentronix, told Outsourcing-Pharma.com. Gentronix launched GreenScreen HC in February and claims its assay gives correct negative results for non-carcinogens, including many which give misleading positive results in other in vitro tests. In addition, GreenScreen only needs a few milligrams of test compound as opposed to the gram quantities required by current regulatory tests. The core technology underlying the GreenScreen product range is a yeast strain that has been genetically modified to produce a Green Fluorescent Protein (GFP) when its DNA damage repair systems are activated. As the damage occurs the cells become increasingly fluorescent, hence acting as indicators for the presence of genotoxic agents. GreenScreen is available commercially to drug companies but the new deal with BioReliance makes Gentronix' assay the first to be available as a service. Under the terms of the deal, BioReliance has agreed to buy a minimum amount of reagent each year at an agreed sum with the option to buy more for a discounted price, said McCulloch. In return Gentronix will cooperate with the CRO on a market education campaign which kicks off next month. "Like with any new technology, there is a lack of awareness and understanding in the industry," said McCulloch. The two companies are conducting seminars to inform industry players on next-generation genotoxicity screening tools, one on 30 October in Boston and a second on 7 November in San Diego.
